FDA.reportPublic FDA data

Potassium Chloride

Product NDC
42806-423
11-digit product format
428060423
Labeler code
42806
Product ID
42806-423_3f74c669-3182-952f-e063-6294a90aad92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA209314
Marketing category
ANDA
Marketing start
2023-08-07
Substance
POTASSIUM CHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Potassium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii660YQ98I10
Rxcui312529, 628953

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-423-01Potassium Chloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1006
42806-423-05Potassium Chloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5006
42806-423-10Potassium Chloride1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-423-01EA - Each42806-4238594d722-482d-45e7-bb33-4174063230db12023-09-05
42806-423-05EA - Each42806-423893dd363-a943-4dbd-ba44-06b43712428b12023-09-05
42806-423-10EA - Each42806-4239a17180f-7ddc-4f8d-a663-6709fd2fb16912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-423POTASSIUM CHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [EPIC PHARMA, LLC]4Current NDC, 3 package rows20240620_00615fad-ad3b-46e8-a89d-48290d937ae2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN00615fad-ad3b-46e8-a89d-48290d937ae26
312529potassium chloride 8 MEQ (600 MG) Extended Release Oral TabletPSN00615fad-ad3b-46e8-a89d-48290d937ae26
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD00615fad-ad3b-46e8-a89d-48290d937ae26
312529potassium chloride 8 MEQ Extended Release Oral TabletSCD00615fad-ad3b-46e8-a89d-48290d937ae26
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY00615fad-ad3b-46e8-a89d-48290d937ae26
312529K+ Chloride 8 MEQ Extended Release Oral TabletSY00615fad-ad3b-46e8-a89d-48290d937ae26
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY00615fad-ad3b-46e8-a89d-48290d937ae26
312529Pot Chloride 8 MEQ Extended Release Oral TabletSY00615fad-ad3b-46e8-a89d-48290d937ae26
312529potassium chloride 600 MG Extended Release Oral TabletSY00615fad-ad3b-46e8-a89d-48290d937ae26
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY00615fad-ad3b-46e8-a89d-48290d937ae26
628953potassium chloride 750 MG Extended Release Oral TabletSY00615fad-ad3b-46e8-a89d-48290d937ae26
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49583
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49583
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49583
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49583
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49583
628953potassium chloride 750 MG Extended Release Oral TabletSY0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49583
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN30527e49-6648-44f3-97b2-9c51783ac0031
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSNbf632e1d-73f3-4df1-ad12-e555fa6a56e91
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN3dfac7ca-2c2e-e709-e063-6394a90adbb31
628953potassium chloride 10 MEQ (750 MG) Extended Release Oral TabletPSN7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce1
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD30527e49-6648-44f3-97b2-9c51783ac0031
628953potassium chloride 10 MEQ Extended Release Oral TabletSCDbf632e1d-73f3-4df1-ad12-e555fa6a56e91
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce1
628953potassium chloride 10 MEQ Extended Release Oral TabletSCD3dfac7ca-2c2e-e709-e063-6394a90adbb31
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY30527e49-6648-44f3-97b2-9c51783ac0031
628953K+ Chloride 10 MEQ Extended Release Oral TabletSYbf632e1d-73f3-4df1-ad12-e555fa6a56e91
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce1
628953K+ Chloride 10 MEQ Extended Release Oral TabletSY3dfac7ca-2c2e-e709-e063-6394a90adbb31
628953Pot Chloride 10 MEQ Extended Release Oral TabletSYbf632e1d-73f3-4df1-ad12-e555fa6a56e91
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce1
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY3dfac7ca-2c2e-e709-e063-6394a90adbb31
628953Pot Chloride 10 MEQ Extended Release Oral TabletSY30527e49-6648-44f3-97b2-9c51783ac0031
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce1
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY3dfac7ca-2c2e-e709-e063-6394a90adbb31
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSYbf632e1d-73f3-4df1-ad12-e555fa6a56e91
628953potassium chloride 750 MG (potassium 10 mEq) Extended Release Oral TabletSY30527e49-6648-44f3-97b2-9c51783ac0031
628953potassium chloride 750 MG Extended Release Oral TabletSY7238d1d5-23c1-44d5-98fc-20d1d4e5a8ce1
628953potassium chloride 750 MG Extended Release Oral TabletSY3dfac7ca-2c2e-e709-e063-6394a90adbb31
628953potassium chloride 750 MG Extended Release Oral TabletSYbf632e1d-73f3-4df1-ad12-e555fa6a56e91
628953potassium chloride 750 MG Extended Release Oral TabletSY30527e49-6648-44f3-97b2-9c51783ac0031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-423-0142806042301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-423-01) 2023-08-07NoNoCurrent
42806-423-0542806042305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-423-05) 2023-08-07NoNoCurrent
42806-423-10428060423101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42806-423-10) 2023-08-07NoNoCurrent